Alcohol dependence is a major medical, social, and legal concern. The economic costs of alcohol dependence in the U.S. are estimated to be around $100 billion per year. Three medications are currently FDA-approved as treatments: disulfuram, acamprosate and naltrexone. Disulfuram has numerous limitations, including dangers from the disulfuram/alcohol reaction and poor treatment adherence. Acamprosate has not been shown to be more effective than placebo in studies conducted in the U.S.; approval was based on positive European studies. Slightly better efficacy outcomes have been obtained for naltrexone, although efficacy is limited to specific genotypes. While not specifically FDA-approved, topiramate is an effective treatment for alcohol dependence. However, in clinical practice, patients find its side effects difficult to tolerate, limiting its effectiveness. Reflecting the poor efficacy of existing treatments, acamprosate (Campral) sales remained barely above $80 million in 2010, whereas injectable naltrexone (Vivitrol) sales were below $25 million in 2012. Together, these figures may indicate that relatively few patients with alcohol dependence receive an effective medication treatment, underscoring an enormous untapped need, as between 5 and 10% of the U.S. population is estimated to have an alcohol use disorder.
The present disclosure appreciates that treatment for substance use disorders and stress disorders may be a challenging endeavor.